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We often get questions from our customers about adherence to different industry standards.  “Which ONE do you follow?” The answer is not as simple as it appears. In fact, the question itself is much more complex. Theories and standards of GAMP, ASTM E2500, ICH Q8, ICH Q9, ICH Q10, and 21CFR part 11 work together opposed to standing independently.

In order to have a sufficient understanding of the relationship among these industry standards, let’s begin with a brief history and some background information regarding GAMP, ASTM E2500, ICH Q8, ICH Q9, and ICH Q10, and 21CFR part 11.

industry timeline

The International Society for Pharmaceutical Engineering (ISPE) is the governing body for GAMP. GAMP has gone through various revisions over the last 25 years since its first primer. Its latest release, back in 2008, was the result of a major rewrite which included significant changes to industry standards. It aligned procedures with the dynamic Life Sciences industry and reduced the cost of compliance. Part of the need for GAMP 5 was driven by the movement towards a more risk based approach to validation. Other guidelines published after GAMP 4 caused the need for revision to GAMP 5. These guidelines included ICH Q8, ICH Q9, ICH Q10 and ASTM E2500. As a result of GAMP 5, all guidance now lives in harmony rather than in conflict with one another.

What are these industry standards all about?

ASTM E2500 is governed by ASTM International. This approach must be documented to an extent based on risk. One unique aspect of ASTM E2500 is that it uses the term “verification” rather than “qualification.” Doing so puts more emphasis on risks, no matter the industry. For example, whether it is in Pharmaceuticals or Medical Devices, a risk is a risk mentality.

ICH Q8, ICH Q9, and ICH Q10 are governed by the International Council on Harmonisation (ICH). Q8 was developed for Pharmaceutical Development; Q9 for Quality Risk Management; and Q10 for Pharmaceutical Quality Systems. Many pharmaceutical and medical device companies have global sales. In turn, they must meet the standards of each country in which they sell.  The ICH was developed to provide guidance that would help bring each of these requirements into a central location. The FDA has adopted these as guidance documents; yet it is important to keep in mind that they are simply guidelines and not regulations.

While GAMP 5’s focus is on automated systems, ASTM E2500 encompasses all production systems, including the automated portions. GAMP 5 aligns with major industry developments including PQLI1, ICH Q8, ICH Q9, ICH Q10, and ASTM E2500. It is applicable to a wide range of information systems. The GAMP guidance aims to achieve computerized systems. These systems use and meet current regulatory requirements by building upon existing industry good practices in an efficient and effective manner. GAMP 5 and E2500 essentially follow the same process of plan, specify, build, verify, and report; with good engineering practice, risk management, design review, and change management encompassing the entire process.

What standards should you follow?

  • Companies that produce pharmaceutical products and medical devices are REQUIRED to follow the FDA’s Good Manufacturing Practices.
  • Certain organizations must comply with International Organization for Standardization (ISO) standards to obtain ISO certification.
  • Following these other guidelines will help corporations be compliant with both FDA and ISO regulations.

What standards does Blue Mountain Quality Resources adhere to?

Blue Mountain’s development is based on the V model of GAMP 5.  It is based on the standards of PQLI1, ICH Q8, ICH Q9, ICH Q10, and ASTM E2500. Blue Mountain’s software is designed to be used in compliance with ISO 9000 and the FDA’s GMPs.

A series of events has driven changes in industry standards; which will likely continue to evolve as technology advances.  One of the obstacles a software development company in the Life Sciences industry routinely faces is the ability to remain current and knowledgeable on all of these developments. Being in the industry since the introduction of GAMP 1, Blue Mountain is confronted with these challenges and knows, firsthand, the importance of staying on top of this industry progression.